N/A N=73 Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics
HIV
Primary: Effect of CYP2B6 Genotype on Efavirenz Clearance — 93.35; 76.08; 51.03; 50.05 ml/h/kg
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=16 Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
HIV Infections · Hepatic Impairment
Primary: Maximum Plasma Concentration (Cmax) — 5.303; 8.964; 6.750; 6.515 micrograms (mcg)/mL
Phase 4 N=70 CYP2B6 Genetics and Drug Interactions in Healthy Volunteers
Healthy
Primary: Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose) — 411.53; 620.36; 522.42; 183.97 h*uM
Phase 1 N=30 Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Healthy
Primary: Maximum Plasma Concentration (Cmax) of Efavirenz — 2,461.58; 2,384.79 ng/mL
Phase 1 N=12 Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Pharmacokinetics · Drug Interactions · Pharmacodynamics
Primary: AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15 — 51.9 ng*h/ml
Phase 1 N=30 A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Healthy
Primary: Pharmacokinetics: Maximum Plasma Concentration (Cmax) — 2.62; 2.63 ug/mL
Phase 2 N=37 Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
HIV Infections
Primary: Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population — 3790; 1998…
Phase 3 N=636 Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
HIV Infections
Primary: Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation — 92.2; 94.1 percentage of participants — p=0.05
Phase 1 N=29 Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Healthy
Primary: Group A - Efavirenz: Cmax — 771.0; 809.0 nmol/L
Phase 4 N=60 FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
HIV Infections
Primary: Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml) — 100; 86 Percentage of Participants
Phase 2 N=13 Efavirenz and Ritonavir on Human Brain P-Glycoprotein
Drug Effects
Primary: Cerebral [11C]dLop Distribution Volume
N/A N=10 Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen
HIV Disease
Primary: Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) — 19.61; 24.54; 6.71; 12.08 arbitrary units
N/A N=10 Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen
HIV · HIV-associated Neurocognitive Disorder · Neurotoxicity
Primary: Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) — 19.38; 18.94; 27.83; 24.95 arbitrary units
Phase 1 N=32 A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
Healthy Subjects · Drug-drug Interaction · Pharmacokinetics
Primary: Maximum Plasma Concentration (Cmax) Following Single Dose of Quizartinib With or Without Efavirenz — 130.0; 238.0; 11.0; 34.4 ng/mL
Phase 2 N=61 Efavirenz in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer
Primary: Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months — 28.3 percentage of participants
Phase 4 N=30 Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients
HIV
Primary: Change in Flow-mediated Dilation (FMD) of the Brachial Artery — -0.67; -0.1 % change from baseline — p=0.67
Phase 3 N=1,857 Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
HIV Infections
Primary: Time From Randomization to Virologic Failure — 36; 24; 24; 24 Weeks
Phase 4 N=31 Genetics and HIV-1 Protease Inhibitors
HIV
Primary: Day 7 Atazanavir Oral Clearance — .25; .18 L/h/kg
Phase 2 N=19 Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
Primary: Percentage of Patients in Non-progression at 2 Months — 14.3 percentage of participants
Phase 1 N=34 Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Hyperlipidemia · HIV
Primary: AUC — 85.3; 62.8 ng*hr/mL
Phase 1 N=25 Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
Solid Tumors · Non-Hodgkin's Lymphoma
Primary: Maximum Tolerated Dose (MTD) of Efavirenz — 1200 mg
Phase 2 N=86 Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
HIV-1 · Central Nervous System
Primary: Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12 — 41.9; 37.2 Percentage of participants…
Phase 4 N=45 Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
HIV Seropositivity · Metabolic Syndrome · Fatty Liver
Primary: Change in Liver Fat — 0.3; 0.6 % hepatic fat fraction
Phase 2 N=79 Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
HIV Infections
Primary: The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the…
Phase 4 N=40 Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress
Cardiovascular Disease
Primary: Change in Flow-mediated Dilation of the Brachial Artery — 0.089; 0.63 absolute percentage change — p=0.30
Phase 2 N=21 Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir
HIV Infections
Primary: Change in Short-term Virologic Response — -.11; -.15; -.16; -.16 log(10) copies/mL per day
Phase 2 N=50 Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
HIV-1 Infection
Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) — 100 percentage of participants
Phase 2 N=50 TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
HIV Infections · Acquired Immunodeficiency Syndrome
Primary: Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax) — 1339; 845.7; 1104; 758.6 ng/ml
Phase 3 N=690 TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
HIV Infections · HIV-1 · Human Immunodeficiency Virus Type 1
Primary: Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 — 287; 285; 38; 15 Participants…
N/A N=13 Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan
Drug Interactions
Primary: AUC of Bosentan — 9540; 5710; 5020 h*ng/ml